Views on hormone therapy for menopause have changed, but many women never got the message
Fact checked by Shannon Sparks
Linda Buckley endured debilitating menopause symptoms for years without relief. Insomnia, night sweats, and pain in her hips and back made sitting very difficult. Then she was diagnosed with osteopenia and osteoporosis.
“It was horrible,” says Buckley, 59, of Old Town.
Hormone replacement therapy changed that — eight years later.
“It was like a miracle,” she says. She only wishes she’d found it sooner.
“I didn’t know much about it because it wasn’t discussed by my doctors,” she says. “I thought I just had to live with it.”
Buckley belongs to a generation of women who missed out on hormone therapy. Doctors steered some away after absorbing decades of warnings that hormone therapy carried more risk than benefit. Others, like Buckley, never knew it was an option.
“Women missed out for 20-plus years, and it’s really unfortunate because the data was misinterpreted, and everyone panicked,” says Patricia Handler, a nurse practitioner at Northwestern Medicine Center for Sexual Medicine and Menopause in Chicago. “Women going through menopause were often told by their physicians, ‘Well, I’m sorry. You’ve just got to kind of live through it.’”
Much of that information gap traces back to 2002, when the Women’s Health Initiative — the largest study of women’s health in history — published a study linking hormone therapy to increased risks of breast cancer, heart disease, and stroke. Roughly half of the estimated 15 million women using hormone replacement therapy at the time stopped treatment within six months, according to Yale School of Medicine. The study also influenced a generation of physicians to avoid prescribing hormone replacement therapy.
“Women missed out for 20-plus years, and it’s really unfortunate because the data was misinterpreted, and everyone panicked.”
By 2003, the U.S. Food and Drug Administration (FDA) required manufacturers to add boxed warnings — commonly called “black box warnings” — to estrogen and estrogen-progestin products, cautioning of increased risks of cardiovascular disease, breast cancer, and dementia.
Researchers later identified the study’s limitations. Participants averaged about 63 years old (roughly a decade beyond menopause), placing many in a higher-risk group for cardiovascular disease. Additionally, researchers evaluated only one formulation: a daily oral combination of estrogen and progestin that other treatment options have largely replaced.
Subsequent research has found that hormone therapy can safely benefit many women who begin treatment before age 60 or within 10 years of menopause by relieving hot flashes and preventing bone loss.
Research has also clarified the role of vaginal estrogen. Genitourinary syndrome of menopause, or GSM, occurs when estrogen levels decline and the tissues in the vagina, vulva, bladder, and urethra become thinner and drier, leading to chronic urinary tract infections, pain, and sexual discomfort. Some menopause experts now argue vaginal estrogen should be standard treatment for most postmenopausal women, not for sexual health, but because thinning vaginal and urinary tissues become more susceptible to urinary tract infections and other complications.
For decades, physicians, researchers, and advocates urged the FDA to reconsider the boxed warnings, arguing that cardiovascular disease, breast cancer, and dementia risks did not apply equally to every form of hormone therapy. They also made a separate case for creams, rings, and other vaginal estrogen products because they carry little systemic risk.
In November 2025, the FDA removed the boxed warning for cardiovascular disease and breast cancer from vaginal estrogen products, replacing it with standard labeling, and eliminated the dementia warning. The boxed warning for endometrial cancer remains for women with a uterus who use estrogen without progestogen. The move marked the first major revision of hormone therapy safety labeling in more than two decades.
The change coincided with a rebound in hormone therapy use. Hormone therapy prescriptions increased 72% from 2021 to 2025, an Epic Research analysis of more than 24 million women found. Prescribing continued to climb during the same quarter that the FDA announced the labeling changes.
However, some experts said the FDA went too far. They criticized public statements by FDA Commissioner Marty Makary and others linking menopause to divorce and shortened life spans. Health and Human Services Secretary Robert F. Kennedy Jr. also claimed that women who take HRT may reduce their risk of Alzheimer’s disease by 35%.
Rather than settling the debate, the FDA’s decision introduced new claims alongside longstanding fears, leaving many women uncertain about what to believe.
To some women, including Buckley, the warnings meant years of untreated symptoms and lingering doubts. Buckley says she still questioned the safety of the estrogen patch when she first started using it until her provider at Northwestern’s menopause clinic explained the treatment to her.
For others, removing the warnings erased fears they had long accepted as fact.
Hormone therapy does not reduce the risk of dementia, despite recent public claims to the contrary, says Pauline Maki, PhD, director of the Center for Health, Awareness, and Research on Menopause at the University of Illinois Chicago. She says the theory that hormone therapy protects against Alzheimer’s disease originated from small observational studies, but larger studies from Finland, Taiwan, and the United Kingdom have found no such benefit.
Hormone therapy remains a safe and effective treatment for many women when used appropriately, Maki and other menopause experts say, even if it cannot deliver every benefit some recent claims have promised.
“There’s no need for women at this point in history to suffer with hot flashes,” Maki says.
Originally published in the Fall 2026/Winter 2027 print issue.
Erika Hobbs is an award-winning journalist, newsroom leader, strategist, storyteller, and coach based in Chicago. As an independent journalist, Erika has written about tackling breast cancer, healthcare inequities in people of color, undocumented immigrants in the Chicago suburbs, and the power of yoga in combating the aging process. Read more
